Effect of Digital Cognitive Training on the Functionality of Older Adults With Mild Cognitive Impairment (MCI)

NCT ID: NCT03911765

Last Updated: 2019-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-02

Study Completion Date

2019-12-02

Brief Summary

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The purpose of this study is to investigate the effect of digital cognitive training in the functionality of older adults with Mild Cognitive Impairment.

Detailed Description

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Mild Cognitive Impairment (MCI) is characterized by decline in one or more cognitive domains, including memory, attention, executive functions, language and visuospatial abilities, and in a significant portion of cases may evolve to Alzheimer's Disease. According to established diagnostic criteria, independence for daily life activities is preserved, but activities are carried out less effectiveness and efficiency, affected subjects usually take more time and make more mistakes, when compared to their pre-morbid performance. Different studies have observed that impairments in functional performance in older adults with MCI are associated with impairments in executive function. This study intends to verify the impact of the use of digital cognitive training for executive function on the functionality of older adults with MCI. Digital cognitive exercises, used in the intervention group, have the primary objective of stimulating executive functions, and will be made available through the Internet using the BrainHQ platform. The active control group will play computer games available online. Both groups will play for 1 hour at least 2 times per week.

After baseline assessments, older adults with MCI will be stratified by age, education, gender, functional measurement and cognitive assessment, and randomly assigned to the intervention group with digital cognitive exercises or to the control group with computer games, in a stepped wedge design. Subjects will be evaluated at baseline and after completing 10 and 20 hours of intervention. After the first 10 hours of intervention both groups will be assigned to the intervention with digital cognitive exercises for additional 10 hours. Both groups will be comparable in terms of personal contact with staff and computer time. Our hypothesis is that the training using digital cognitive exercises will improve the executive function and that this gain has a positive impact on the functionality and accomplishment of the daily life activities of older adults with MCI.

Conditions

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Mild Cognitive Impairment Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Stepped wedge
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Executive Function cognitive training

20 hours of digital cognitive training targeting executive function.

Group Type EXPERIMENTAL

digital cognitive training

Intervention Type BEHAVIORAL

Digital cognitive exercises, used in the intervention group, have the primary objective of stimulating executive functions, and will be made available through the Internet using the BrainHQ platform.

Games

10 hours of computer games c available online which do not involve a high demand in cognitive functions (e.g. fishing game, pinball game, tetris, etc), followed by 10 hours of of digital cognitive training targeting executive function.

Group Type ACTIVE_COMPARATOR

digital cognitive training

Intervention Type BEHAVIORAL

Digital cognitive exercises, used in the intervention group, have the primary objective of stimulating executive functions, and will be made available through the Internet using the BrainHQ platform.

Interventions

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digital cognitive training

Digital cognitive exercises, used in the intervention group, have the primary objective of stimulating executive functions, and will be made available through the Internet using the BrainHQ platform.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age above 65 years old;
* Elderly enrolled in home for aged in wich the research is taking place;
* Montreal Cognitive Assessment above 21 points;

Exclusion Criteria

* Clinical diagnosis of Alzheimer's Disease;
* Serious medical or neurological condition preventing from participation in the study;
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Rogerio Panizzutti

Director, Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Rogério Panizzutti

Role: CONTACT

21999090498 ext. 55

Facility Contacts

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Rogério Panizzutti, MD, Phd

Role: primary

5521999090498

Aline D'Avila, MSc

Role: backup

5531987778981

Other Identifiers

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17976113.1.0000.5257

Identifier Type: -

Identifier Source: org_study_id

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